Bulk Pharmaceutical API Sources for IVADANTIN

Bulk Pharmaceutical API Sources for IVADANTIN

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemBridge		5492202
Sigma-Aldrich		N7878_SIGMA
NovoSeek		6604200
NovoSeek		9562058
ISpharm		I07-0015
MolPort		MolPort-001-018-217

Bulk Active Pharmaceutical Ingredient (API) Sources for IVADANTIN

Last updated: July 30, 2025

Introduction

In the global pharmaceutical landscape, the sourcing of Active Pharmaceutical Ingredients (APIs) is pivotal to ensuring the consistent quality, efficacy, and supply of intravenous antifungal agents like IVADANTIN. As the primary active component in the medication, the API must adhere to strict regulatory standards, including Good Manufacturing Practices (GMP), to guarantee patient safety and therapeutic effectiveness.

Understanding IVADANTIN and Its API

IVADANTIN relies on fluconazole as its API, a triazole antifungal agent widely used for treating invasive fungal infections. Fluconazole's broad spectrum activity against Candida and Cryptococcus species makes it a crucial pharmaceutical ingredient. The demand for high-quality fluconazole APIs has surged, given the expanding indications and injection formulations requiring sterility and stability.

Global API Manufacturers and Sources

The supply chain for fluconazole APIs is diversified, encompassing several reputable manufacturers globally. Suppliers vary from large-scale API producers in India, China, Italy, and the United States, to contract manufacturing organizations (CMOs) that focus on high-volume, compliant production.

Major API Manufacturers for Fluconazole

1. Zhejiang Gino Pharmaceutical Co., Ltd. (China)
   Recognized for manufacturing bulk fluconazole API, Zhejiang Gino Pharmaceutical operates under strict GMP standards. Their facilities are certified by international regulatory bodies, ensuring product compliance for global markets.

2. Tianjin Zhongxin Pharmaceutical Group Co., Ltd. (China)
   An established producer with a significant presence in antifungal APIs, Zhongxin offers fluconazole API that meets pharmacopeia standards, with extensive quality control measures.

3. BASF SE (Germany)
   While primarily known for specialty chemicals, BASF manufactures pharmaceutical intermediates including APIs. Their global footprint and compliance standards make them a significant player in the high-purity API supply.

4. Hikma Pharmaceuticals (UK/Jordan)
   Hikma has manufacturing capabilities for sterile APIs and injectable formulations. Their fluconazole API production adheres to international GMP requirements, primarily supplying licensed formulations.

5. Apotex Inc. (Canada)
   Apotex produces generic APIs, including fluconazole, with a focus on quality and regulatory compliance for North American and international markets.

6. Sandoz (Novartis) (Switzerland)
   As part of Novartis, Sandoz offers high-quality APIs, including fluconazole, with stringent adherence to GMP and regulatory standards.

7. Sun Pharmaceutical Industries Ltd. (India)
   A global leader in generics, Sun Pharma supplies fluconazole API with a focus on affordability and compliance with international standards.

8. Dr. Reddy’s Laboratories (India)
   Reddy’s API manufacturing units produce fluconazole according to strict quality benchmarks, paralleling international pharmacopoeial standards.

9. Cipla Limited (India)
   Cipla maintains a strong API production capacity for antifungal agents, including fluconazole, with comprehensive quality assurance processes.

10. Serum Institute of India (India)
    Known as a vaccine giant, Serum also produces APIs, including fluconazole, with GMP certification for injectable APIs.

Key Considerations in API Sourcing

• Regulatory Certification: Suppliers must hold certifications from authoritative bodies such as the US FDA, EMA, TGA, or local GMP certificates to ensure compliance.
• Quality Assurance: Routine audits, quality control testing, and stability studies are critical, especially for injectable APIs that require sterile and endotoxin-free products.
• Manufacturing Capacity: Ability to meet global demand with scalable production facilities.
• Pricing and Supply Stability: A balance between cost-effectiveness and reliable delivery timelines is essential for maintaining supply chain integrity.
• Intellectual Property and Licensing: Importantly, some sources operate under licensing agreements, affecting geographic distribution rights.

Emerging Markets and Regional Suppliers

India's API industry, in particular, has expanded, driven by cost competitiveness and capacity for large-scale production. Companies like Divi's Laboratories and Biocon are also notable players in antifungal API manufacturing. Chinese suppliers continue to grow in prominence due to increasing capacity and investment into GMP-compliant facilities.

Supply Chain Challenges

Disruptions in API supply chains can arise from regulatory changes, geopolitical tensions, API export restrictions, or raw material shortages. Notably, the COVID-19 pandemic exposed vulnerabilities, prompting pharmaceutical companies to diversify supplier bases and strengthen regional production.

Regulatory and Quality Compliance

Compliance with MPH (Medicines and Healthcare products Regulatory Agency), FDA 21 CFR Part 211, and European Pharmacopoeia standards is non-negotiable for APIs used in injectable formulations. Certification of analytical procedures and batch consistency testing underpin the trustworthiness of supply sources.

Future Outlook

Advances in manufacturing technology—such as continuous flow synthesis and improved purification methods—are expected to enhance the quality and scalability of fluconazole APIs. Additionally, shifts toward local production in different countries aim to mitigate dependency on specific regions and enhance supply resilience.

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Key Takeaways

• The primary API for IVADANTIN (fluconazole) is produced by reputable suppliers across China, India, Europe, and North America.
• Stringent regulatory compliance and GMP certification are critical factors when selecting an API source.
• Diversification of supply sources is essential to mitigate risks related to global disruptions.
• Emerging manufacturing technologies are poised to improve API quality, cost, and supply flexibility.
• Collaboration with trusted contract manufacturers and conducting rigorous quality assessments can ensure a stable API supply chain.

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FAQs

1. Which are the leading manufacturers of fluconazole API for injectable formulations?
Leading manufacturers include Zhejiang Gino Pharmaceutical, Tianjin Zhongxin Pharmaceutical, Sun Pharmaceutical Industries, Hikma Pharmaceuticals, and Apotex, all adhering to GMP standards and regulatory certifications.

2. What are the key criteria for selecting an API supplier for IVADANTIN?
Regulatory compliance (certifications from FDA, EMA, etc.), consistent quality, GMP adherence, manufacturing capacity, supply reliability, and cost-effectiveness.

3. Are Chinese and Indian API manufacturers reliable for high-quality fluconazole?
Yes, many Chinese and Indian manufacturers have achieved international GMP certification and comply with global pharmaceutical regulatory standards, making them reliable sources.

4. How does supply chain disruption impact API sourcing for IVADANTIN?
Disruptions can lead to shortages, increased costs, and delays in production. Diversifying sources and maintaining strategic stockpiles mitigate these risks.

5. What are the future trends in API manufacturing for antifungal agents?
Emerging trends include the adoption of continuous manufacturing, automation, and advanced purification techniques to improve quality and scalability, along with regional production initiatives to reduce dependency on specific markets.

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Sources:

1. [1] US FDA Database on Approved APIs.
2. [2] European Medicines Agency (EMA) GMP Certification Records.
3. [3] Industry Reports on API Manufacturing in China and India.
4. [4] Company Websites and Annual Reports.
5. [5] WHO Prequalification Lists for APIs.

Note: All cited sources pertain to publicly available regulatory filings, industry reports, and company disclosures as of the knowledge cutoff in 2023.